Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial

Arnold, Donald M.; Heddle, Nancy M.; Cook, Richard J.; Hsia, Cyrus C.; Blostein, Mark; Jamula, Erin; Sholzberg, Michelle; Lin, Yulia; Kassis, Jeannine; Tinmouth, Alan; Amini, Sufia; Schipperus, Martin R.; Lim, Wendy; Vishnu, Prakash; Warner, Margaret R.; Carruthers, Julie; Li, Na; Lane, Shannon; Kelton, John G.

doi:10.1016/s2352-3026(20)30227-1

Cited by 17 publications

(10 citation statements)

References 27 publications

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“…In the first and second trimesters, the indication for treatment is a platelet count < 20 × 10 9 /L. For vaginal or Caesarean delivery, a platelet count ≥ 50 × 10 9 /L is generally adequate 94 …”

Section: Special Situationsmentioning

confidence: 99%

Consensus guidelines for the management of adult immune thrombocytopenia in Australia and New Zealand

Choi

Merriman

Bennett

et al. 2021

Medical Journal of Australia

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Introduction The absence of high quality evidence for basic clinical dilemmas in immune thrombocytopenic purpura (ITP) underlines the need for contemporary guidelines relevant to the local treatment context. ITP is diagnosed by exclusions, with a hallmark laboratory finding of isolated thrombocytopenia. Main recommendations Bleeding, family and medication histories and a review of historical investigations are required to gauge the bleeding risk and possible hereditary syndromes. Beyond the platelet count, the decision to treat is affected by individual bleeding risk, disease stage, side effects of treatment, concomitant medications, and patient preference. Treatment is aimed at achieving a platelet count > 20 × 109/L, and avoidance of severe bleeding. Steroids are the standard first line treatment, with either 6‐week courses of tapering prednisone or repeated courses of high dose dexamethasone providing equivalent efficacy. Intravenous immunoglobulin can be used periprocedurally or as first line therapy in combination with steroids. Changes in management as a result of this statement There is no consensus on choice of second line treatments. Options with the most robust evidence include splenectomy, rituximab and thrombopoietin receptor agonists. Other therapies include azathioprine, mycophenolate mofetil, dapsone and vinca alkaloids. Given that up to one‐third of patients achieve a satisfactory haemostatic response, splenectomy should be delayed for at least 12 months if possible. In life‐threatening bleeding, we recommend platelet transfusions to achieve haemostasis, along with intravenous immunoglobulin and high dose steroids.

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Section: Special Situationsmentioning

confidence: 99%

Consensus guidelines for the management of adult immune thrombocytopenia in Australia and New Zealand

Choi

Merriman

Bennett

et al. 2021

Medical Journal of Australia

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“… 148 , 149 In the first randomized trial of perioperative management of ITP, eltrombopag was noninferior to intravenous immunoglobulin in terms of achieving and maintaining target platelet counts during the perioperative period. 152 However, it should be noted that for both romiplostim and eltrombopag, the amount of time needed before surgery to increase platelet counts could be problematic if a patient requires a procedure on a more immediate basis. The best treatment approaches under such circumstances (ie, TPO-RA versus intravenous immunoglobulin, dose, and timing of treatment) have been raised for the use of eltrombopag before and after surgery 153 and also need further consideration for romiplostim.…”

Section: Clinical Evidence and Rationale For Use Of Romiplostim Beyond Itpmentioning

confidence: 99%

A Review of Romiplostim Mechanism of Action and Clinical Applicability

Bussel¹,

Soff²,

Balduzzi³

et al. 2021

DDDT

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Thrombocytopenia results from a variety of conditions, including radiation, chemotherapy, autoimmune disease, bone marrow disorders, pathologic conditions associated with surgical procedures, hematopoietic stem cell transplant (HSCT), and hematologic disorders associated with severe aplastic anemia. Immune thrombocytopenia (ITP) is caused by immune reactions that accelerate destruction and reduce production of platelets. Thrombopoietin (TPO) is a critical component of platelet production pathways, and TPO receptor agonists (TPO-RAs) are important for the management of ITP by increasing platelet production and reducing the need for other treatments. Romiplostim is a TPO-RA approved for use in patients with ITP in the United States, European Union, Australia, and several countries in Africa and Asia, as well as for use in patients with refractory aplastic anemia in Japan and Korea. Romiplostim binds to and activates the TPO receptor on megakaryocyte precursors, thus promoting cell proliferation and viability, resulting in increased platelet production. Through this mechanism, romiplostim reduces the need for other treatments and decreases bleeding events in patients with thrombocytopenia. In addition to its efficacy in ITP, studies have shown that romiplostim is effective in improving platelet counts in various settings, thereby highlighting the versatility of romiplostim. The efficacy of romiplostim in such disorders is currently under investigation. Here, we review the structure, mechanism, pharmacokinetics, and pharmacodynamics of romiplostim. We also summarize the clinical evidence supporting its use in ITP and other disorders that involve thrombocytopenia, including chemotherapy-induced thrombocytopenia, aplastic anemia, acute radiation syndrome, perisurgical thrombocytopenia, post-HSCT thrombocytopenia, and liver disease.

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“…Therefore, they have a role in patients with ITP needing a temporary rise in platelet count prior to invasive procedures [50][51][52][53]. Eltombopag proved to be as effective as IVIG in patients with ITP, but may carry an increased risk of thrombosis [54].…”

Section: Thrombopoietin Receptor Agonistsmentioning

confidence: 99%

Perioperative thrombocytopenia

Lombard

Popescu

Oprea

et al. 2021

Current Opinion in Anaesthesiology

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Purpose of reviewIn this review, we discuss recent developments and trends in the perioperative management of thrombocytopenia. Recent findingsLarge contemporary data base studies show that preoperative thrombocytopenia is present in about 8% of asymptomatic patients, and is associated with increased risks for bleeding and 30-day mortality. Traditionally specific threshold platelet counts were recommended for specific procedures. However, the risk of bleeding may not correlate well with platelet counts and varies with platelet function depending on the underlying etiology. Evidence to support prophylactic platelet transfusion is limited and refractoriness to platelet transfusion is common. A number of options exist to optimize platelet counts prior to procedures, which include steroids, intravenous immunoglobulin, thrombopoietin receptor agonists, and monoclonal antibodies. In addition, intraoperative alternatives and adjuncts to transfusion should be considered. It appears reasonable to use prophylactic desmopressin and antifibrinolytic agents, whereas activated recombinant factor VII could be considered in severe bleeding. Other options include enhancing thrombin generation with prothrombin complex concentrate or increasing fibrinogen levels with fibrinogen concentrate or cryoprecipitate.

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Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial

Cited by 17 publications

References 27 publications

Consensus guidelines for the management of adult immune thrombocytopenia in Australia and New Zealand

Consensus guidelines for the management of adult immune thrombocytopenia in Australia and New Zealand

A Review of Romiplostim Mechanism of Action and Clinical Applicability

Perioperative thrombocytopenia

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